MAUDE Adverse Event Report: DEPUY MITEK MITEK LUPINE SPIRAL FLUTED DRILL BIT; ANCHOR INSTRUMENTS

Catalog Number 211042

Device Problem Metal Shedding Debris (1804)

Patient Problem No Known Impact Or Consequence To Patient (2692)

Event Date 08/19/2015

Event Type  malfunction  

Manufacturer Narrative

Attempts have been made to retrieve additional information about the event and device.The additional information will reportedly be forwarded to depuy synthes mitek however it is not known if it will be received within the 30 day reporting requirement, therefore depuy synthes mitek would like to file this initial medwatch report at this time.When and if additional information is received it will be reflected in a follow-up medwatch report.In transit.

Event Description

The sales rep reported that during a shoulder procedure the customer's lupine spiral fluted drill bit created a small amount of metal shavings in the patient.The sales rep stated that the surgeon stopped immediately and used a shaver to remove all the metal shavings.The sales rep stated that he believes the device is bent.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep was unable to read the lot number for the device but stated that the device is approximately two years and heavily used in the field.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.The following additional information was received via phone from the sales rep on 09/15/2015: the customer's lupine hybrid fish mouth drill guide (green handle) was used with the drill bit during this procedure.The device will also be returning for evaluation.See associated medwatch # 1221934-2015-00977.

Manufacturer Narrative

The complaint device was received and evaluated.Visual observation confirms the laser markings on the device are slightly faded, but there was no damage to the device that would have contributed in the reported failure.The device appears worn indicating heavy use.The reported failure was found to be caused by the damaged guide, and not the drill.A review into the depuy synthes mitek complaints system revealed no other complaints of any kind for this lot of devices that were released to distribution.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

The sales rep reported that during a shoulder procedure the customer's lupine spiral fluted drill bit created a small amount of metal shavings in the patient.The sales rep stated that the surgeon stopped immediately and used a shaver to remove all the metal shavings.The sales rep stated that he believes the device is bent.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep was unable to read the lot number for the device but stated that the device is approximately two years and heavily used in the field.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.The following additional information was received via phone from the sales rep on 09-15-15: the customer's lupine hybrid fish mouth drill guide (green handle) was used with the drill bit during this procedure.The device will also be returning for evaluation.See associated medwatch # 1221934-2015-00977.

Manufacturer Narrative

The complaint device has not been returned, despite requesting for it several times, therefore unavailable for a physical evaluation.Furthermore, no lot numbers were supplied which precludes conducting a batch history review or a lot specific search in the complaints handling system.At this point in time, no corrective action is required and no further action is warranted.This file will remain receptive to any potential forthcoming information received that is pertinent and germane to this issue.However, depuy synthes mitek will continue to track any related complaints within this device family as a means of monitoring the extent with which this complaint is observed in the field.

Event Description

The sales rep reported that during a shoulder procedure the customer's lupine spiral fluted drill bit created a small amount of metal shavings in the patient.The sales rep stated that the surgeon stopped immediately and used a shaver to remove all the metal shavings.The sales rep stated that he believes the device is bent.The sales rep reported that the surgeon completed the procedure with another like device with no patient consequences or delays.The sales rep was unable to read the lot number for the device but stated that the device is approximately two years and heavily used in the field.The sales rep was not present for the case therefore could not provide any further information.The device will be returning for evaluation.The following additional information was received via phone from the sales rep on 09-15-15: the customer's lupine hybrid fish mouth drill guide (green handle) was used with the drill bit during this procedure.The device will also be returning for evaluation.See associated medwatch # 1221934-2015-00977.

• Brand Name: MITEK LUPINE SPIRAL FLUTED DRILL BIT
• Type of Device: ANCHOR INSTRUMENTS
• Manufacturer (Section D): DEPUY MITEK; 325 paramount drive; quality department; raynham MA 02767
• Manufacturer (Section G): DEPUY MITEK; 325 paramount drive; na; raynham MA 02767
• Manufacturer Contact: bahaa nashed ; 325 paramount drive; quality department; raynham, MA 02767 ; 8003824682
• MDR Report Key: 5080587
• MDR Text Key: 26002935
• Report Number: 1221934-2015-00976
• Device Sequence Number: 1
• Product Code: HTW
• Combination Product (y/n): N
• Reporter Country Code: US
• PMA/PMN Number: EXEMPT
• Number of Events Reported: 1
• Summary Report (Y/N): N
• Report Source: Manufacturer
• Source Type: company representative,health
• Reporter Occupation: Health Professional
• Remedial Action: Other
• Type of Report: Followup,Followup
• Report Date: 08/19/2015

1 Device was Involved in the Event

1 Patient was Involved in the Event

• Date FDA Received: 09/16/2015
• Is this an Adverse Event Report?: No
• Is this a Product Problem Report?: Yes
• Device Operator: Health Professional
• Device Catalogue Number: 211042
• Was Device Available for Evaluation?: Device Returned to Manufacturer
• Date Returned to Manufacturer: 10/19/2015
• Is the Reporter a Health Professional?: Yes
• Distributor Facility Aware Date: 08/19/2015
• Device Age: 2 YR
• Event Location: Hospital
• Date Report to Manufacturer: 08/19/2015
• Date Manufacturer Received: 08/19/2015
• Was Device Evaluated by Manufacturer?: Yes
• Is the Device Single Use?: No
• Is This a Reprocessed and Reused Single-Use Device?: No
• Type of Device Usage: Reuse
• Patient Sequence Number: 1